AMPHETAMINE SULFATE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E)

제공처:

Aurolife Pharma, LLC

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Amphetamine Sulfate Tablets USP are indicated for: - Narcolepsy - Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. - Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patient’s refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY ) should be weighed against possible risks inherent in use of the drug, such as those described below. ·         Known hypersensitivity to amphetamine products. ·         During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result) (see WARNINGS). Controlled Substance Amphetamine Sulfate Tablets contains amphetamine, a Schedule II controlled substance. Abuse Amphetamine Sulfate Tablets has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see WARNINGS). Amphetamine Sulfate Tablets can be diverted for non-medical use into illicit channels or distribution. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of amphetamines may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including amphetamine sulfate, can result in overdose and death (see OVERDOSAGE), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.   Dependence Physical Dependence Amphetamine Sulfate Tablets may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including Amphetamine Sulfate Tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. Tolerance Amphetamine Sulfate Tablets may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

제품 요약:

Amphetamine Sulfate Tablets USP is supplied as follows:   5 mg: White to off white, round tablet, debossed "U150" on one side, and "5" with a score on the other side. Bottles of 100 tablets                    NDC 13107-259-01. 10 mg: Light Blue to Blue, slight mottled, "U151" on one side, and "10" with a doubled score on the other side.  Bottles of 100 tablets                    NDC 13107-260-01. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a well-closed container, as defined in the USP. Dispense with Medication Guide available at www.aurobindousa.com/medication-guides   Manufactured for: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Revised:01/2024

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

AMPHETAMINE SULFATE - AMPHETAMINE SULFATE TABLET
Aurolife Pharma, LLC
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MEDICATION GUIDE
Amphetamine Sulfate Tablets (am-FET-uh-meen SULL-fate) , CII
What is the most important information I should know about Amphetamine
Sulfate Tablets, USP?
Amphetamine Sulfate Tablets may cause serious side effects, including:
· · Abuse, misuse, and addiction. Amphetamine Sulfate Tablets has a
high chance for abuse and
misuse and may lead to substance use problems, including addiction.
Misuse and abuse of Amphetamine
Sulfate Tablets , other amphetamine containing medicines, and
methylphenidate, can lead to overdose and
death. The risk of overdose and death is increased with higher doses
of Amphetamine Sulfate Tablets or
when it is used in ways that are not approved, such as snorting or
injection.
o Your healthcare provider should check you or your child’s risk for
abuse, misuse, and addiction before
starting treatment withAmphetamine Sulfate Tablets and will monitor
you or your child during treatment.
o Amphetamine Sulfate Tablets may lead to physical dependence after
prolonged use, even if taken as
directed by your healthcare provider.
o Do not give Amphetamine Sulfate Tablets to anyone else. See “What
is Amphetamine Sulfate
Tablets?” for more information.
o Keep Amphetamine Sulfate Tablets in a safe place and properly
dispose of unused medicine. See
“How should I store Amphetamine Sulfate Tablets?” for more
information.
o Tell your healthcare provider if you or your child have ever abused
or been dependent on alcohol,
prescription medicines, or street drugs.
· ·Risks for people with serious heart disease
Sudden death has happened in people who have heart defects or other
serious heart disease.
Your healthcare provider should check you or your child carefully for
heart problems before starting
Amphetamine Sulfate Tablets.
Tell your healthcare provider if you or your child have any heart
problems, heart disease or heart defects.
Call your healthcare provider or go to the nearest hospital emergency
room ri

제품 특성 요약

AMPHETAMINE SULFATE - AMPHETAMINE SULFATE TABLET
AUROLIFE PHARMA, LLC
----------
AMPHETAMINE SULFATE TABLET USP CII
WARNING
WARNING: ABUSE, MISUSE, AND ADDICTION
AMPHETAMINE SULFATE TABLET HAS A HIGH POTENTIAL FOR ABUSE AND
MISUSE, WHICH CAN LEAD TO THE DEVELOPMENT OF A SUBSTANCE USE
DISORDER, INCLUDING ADDICTION. MISUSE AND ABUSE OF CNS
STIMULANTS, INCLUDING AMPHETAMINE SULFATE, CAN RESULT IN
OVERDOSE AND DEATH (SEE OVERDOSAGE)], AND THIS RISK IS
INCREASED WITH HIGHER DOSES OR UNAPPROVED METHODS OF
ADMINISTRATION, SUCH AS SNORTING OR INJECTION.
BEFORE PRESCRIBING AMPHETAMINE SULFATE TABLET, ASSESS EACH PATIENT’S
RISK FOR ABUSE, MISUSE, AND ADDICTION. EDUCATE PATIENTS AND THEIR
FAMILIES
ABOUT THESE RISKS, PROPER STORAGE OF THE DRUG, AND PROPER DISPOSAL OF
ANY UNUSED DRUG. THROUGHOUT AMPHETAMINE SULFATE TABLET TREATMENT,
REASSESS EACH PATIENT’S RISK OF ABUSE, MISUSE, AND ADDICTION AND
FREQUENTLY MONITOR FOR SIGNS AND SYMPTOMS OF ABUSE, MISUSE, AND
ADDICTION [(SEE WARNINGS AND DRUG ABUSE AND DEPENDENCE)].
DESCRIPTION
Amphetamine Sulfate is a sympathomimetic amino of the amphetamine
group. It is a
white, odorless crystalline powder. It has a slightly bitter taste.
Its solutions are acid to
litmus, having a pH of 5.0 to 6.0. It is freely soluble in water and
slightly soluble in
alcohol.
Each tablet, for oral administration contains 5 mg or 10 mg of
amphetamine sulfate.
Each tablet also contains the following inactive ingredients:
crospovidone, silicified
microcrystalline cellulose and stearic acid. The 10 mg tablet also
contains FD&C Blue #1.
Structural Formula:
FDA approved dissolution test specifications differ from USP
CLINICAL PHARMACOLOGY
Amphetamines are non-catecholamine, sympathomimetic amines with CNS
stimulant
activity. Peripheral actions include elevations of systolic and
diastolic blood pressures,
and weak bronchodilator, and respiratory stimulant action.
Amphetamine, as the racemic form, differs from dextroamphetamine in a
number of
ways. The l-isomer is more potent than the d-isomer in cardiovascula